Velaglucerase alfa

Generic Name: velaglucerase alfa (VEL-a-GLOO-ser-ase AL-fa)
Brand Name: Vpriv

Velaglucerase alfa is used for:

Treating type I Gaucher disease.

Velaglucerase alfa is an enzyme. It breaks down a substance (glucocerebroside) that builds up in the body in patients with Gaucher disease. This helps to decrease the harmful effects of the disease.

Do NOT use velaglucerase alfa if:

• you are allergic to any ingredient in velaglucerase alfa, unless your doctor tells you otherwise

Contact your doctor or health care provider right away if any of these apply to you.

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Before using velaglucerase alfa:

Some medical conditions may interact with velaglucerase alfa. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with velaglucerase alfa. However, no specific interactions with velaglucerase alfa are known at this time.

Ask your health care provider if velaglucerase alfa may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use velaglucerase alfa:

Use velaglucerase alfa as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Velaglucerase alfa is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using velaglucerase alfa at home, a health care provider will teach you how to use it. Be sure you understand how to use velaglucerase alfa. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Gently swirl velaglucerase alfa when mixing. Do not shake.
• If velaglucerase alfa contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of velaglucerase alfa, contact your doctor for advice on when to schedule the next dose.

Ask your health care provider any questions you may have about how to use velaglucerase alfa.

Important safety information:

• Velaglucerase alfa may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use velaglucerase alfa with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Infusion-related reactions may occur with velaglucerase alfa. These reactions have usually been mild, and have occurred mostly within the first 6 months of treatment with velaglucerase alfa. Tell your doctor if you experience headache, dizziness, nausea, tiredness, weakness, or fever when you receive velaglucerase alfa.
• Caution is advised when using velaglucerase alfa in CHILDREN; they may be more sensitive to it effects, especially the risk of upper respiratory tract infection, fever, rash, and decreased blood clotting.
• Velaglucerase alfa should be used with extreme caution in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, contact your doctor. You will need to discuss the benefits and risks of using velaglucerase alfa during pregnancy. It is not known if velaglucerase alfa is found in breast milk. If you are or will be breast-feeding while you are using velaglucerase alfa, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of velaglucerase alfa:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back or joint pain; dizziness; fever; headache; nausea; stomach pain; tiredness; upper respiratory tract infection; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast heartbeat; severe or persistent dizziness or headache; unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Velaglucerase alfa is usually handled and stored by a health care provider. If you are using velaglucerase alfa at home, store velaglucerase alfa as directed by your pharmacist or health care provider. Keep velaglucerase alfa out of the reach of children and away from pets.

General information:

• If you have any questions about velaglucerase alfa, please talk with your doctor, pharmacist, or other health care provider.
• Velaglucerase alfa is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
• Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take velaglucerase alfa or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about velaglucerase alfa. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to velaglucerase alfa. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using velaglucerase alfa.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.